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NDC 65086-0002-05 Omlonti 0.02 mg/mL Details
Omlonti 0.02 mg/mL
Omlonti is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Santen Incorporated. The primary component is OMIDENEPAG ISOPROPYL.
Product Information
NDC | 65086-0002 |
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Product ID | 65086-002_074cf154-7476-e203-e063-6294a90ab60e |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Omlonti |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | omidenepag isopropyl |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | SOLUTION/ DROPS |
Route | OPHTHALMIC |
Active Ingredient Strength | 0.02 |
Active Ingredient Units | mg/mL |
Substance Name | OMIDENEPAG ISOPROPYL |
Labeler Name | Santen Incorporated |
Pharmaceutical Class | Prostaglandin E2 Receptor Agonist [EPC], Prostaglandin E2 Receptor Agonists [MoA] |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA215092 |
Listing Certified Through | 2024-12-31 |
Package
NDC 65086-0002-05 (65086000205)
NDC Package Code | 65086-002-05 |
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Billing NDC | 65086000205 |
Package | 1 BOTTLE, PLASTIC in 1 CARTON (65086-002-05) / 2.5 mL in 1 BOTTLE, PLASTIC |
Marketing Start Date | 2022-09-23 |
NDC Exclude Flag | N |
Pricing Information | N/A |